Trial · NCT00006478
Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation in Treating Non-Hodgkin's Lymphoma
NCT00006478, Phase 2, Terminated, University of Nebraska; results first posted 2010-11-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation in Treating Non-Hodgkin's Lymphoma. Trials, record NCT00006478. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00006478
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation in Treating Non-Hodgkin's Lymphoma
- NCT number
- NCT00006478
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- University of Nebraska
- Conditions
- Lymphoma
- Interventions
- autologous tumor cell vaccine, keyhole limpet hemocyanin, sargramostim, adjuvant therapy
- First posted
- 2003-01-27
- Last updated
- 2023-09-18
- Results first posted
- 2010-11-17
- Limitations and caveats
- The Sponsor Genitope suspend development of MyVax in light of the decision made by the FDA March 6, 2008, therefore this trial was halted prematurely leaving insufficient data to analyze.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Humoral and Cellular Immune Response | immune responses will be obtained prior to first immunization (baseline), prior to the 5th, 6th, 7th immunization series and 2 weeks following administration of the 7th immunization series. And then obtained annually until disease progression | evaluate the humoral immune responses and cellular immune responses to idiotype vaccine with KLH and GM-CSF adjuvant given to patients with follicular lymphoma following high-dose chemotherapy and autologous stem cell transplantation |
| Secondary | Safety of Idiotype Vaccine | At each immunization and at study completion | To evaluate the safety of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting |
| Secondary | Toxicity of Idiotype Vaccine | At each immunization and at study completion | To evaluate the toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting |
| Secondary | Changes in Quantitative Bcl-2 | 1 year post transplant evaluation and then annually until disease progression | To evaluate changes in quantitative bcl-2 of the blood and bone marrow prior to and at various time points following the series of idiotype vaccines. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Humoral and Cellular Immune Response | immune responses will be obtained prior to first immunization (baseline), prior to the 5th, 6th, 7th immunization series and 2 weeks following administration of the 7th immunization series. And then obtained annually until disease progression | NO formal analysis was completed as this trial was halted prematurely. Thirty patients were to be enrolled in the protocol so that 15 patients would be evaluable at the end of the immunization process. Of the 19 patients enrolled on the trial, only 12 went on to complete the vaccine series. | ||
| SECONDARY | Safety of Idiotype Vaccine | At each immunization and at study completion | The study was terminated early and was not analyzed. At this time, the evaluation of this data is unknown as it has been purged. | ||
| SECONDARY | Toxicity of Idiotype Vaccine | At each immunization and at study completion | The study was terminated early and was not analyzed. At this time, the evaluation of this data is unknown as it has been purged. | ||
| SECONDARY | Changes in Quantitative Bcl-2 | 1 year post transplant evaluation and then annually until disease progression | The study was terminated early and was not analyzed. At this time, the evaluation of this data is unknown as it has been purged. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vaccine Therapy | 19 | |
| Overall Study | COMPLETED | Vaccine Therapy | 12 | |
| Overall Study | NOT COMPLETED | Vaccine Therapy | 7 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vaccine Therapy | ||
| Total, other adverse events | Vaccine Therapy | 0 | 19 |
| Total, serious adverse events | Vaccine Therapy | 0 | 19 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA036727 | Buffett Cancer Center Support Grant | SWEASY, JOANN B. | UNIVERSITY OF NEBRASKA MEDICAL CENTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00006478
GET https://conductscience.org/api/trials/v1/NCT00006478/registered